Senior SW Compliance Specialist – Regulatory Affairs, Design Assurance
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Job Description
Responsible for regulatory and quality processes at Meridian Bioscience. Supports compliance activities through the product lifecycle in the medical device sector.
Responsibilities:
- Responsible for supporting Meridian’s regulatory and quality processes
- Assist the regulatory department with product compliance throughout all stages of the product lifecycle
- Provide support and guidance to quality and regulatory activities, including Design Control activities
- Supports and helps draft sections of regulatory submissions for domestic, worldwide commercialization
- Drafts, evaluates, and reviews technical protocols and data in support of clinical trials
- Reviews software architecture, software requirements, traceability, verification and validation documentation
- Provides direct support associated with adverse events, medical device reportable events and product recall activities
- Supports cybersecurity compliance activities
Requirements:
- Bachelor of Science degree in Biology, Biochemistry, Microbiology, Software Engineering, Computer Science, Computer Engineering, Biomedical Engineering, Electrical Engineering, or other related scientific, engineering, or technical discipline required
- A minimum of 4–6 years of direct Regulatory Affairs, Design Assurance, Software Quality, or related regulated industry experience is required
- Proven knowledge of FDA and ISO regulated environment
- Experience with design, development, and clearance of medical devices
- Knowledge of FDA software documentation requirements
- Experience reviewing software lifecycle documentation
- Working knowledge of cybersecurity requirements applicable to medical devices
- Ability to assess software, firmware, cybersecurity, and connectivity changes for regulatory impact
Benefits:
- Health insurance
- Flexible work arrangements
- Professional development opportunities
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